Development and Validation of Ratio Spectra Derivative Spectrophotometric Method for Estimation of Chlorpheniramine Maleate and Diphenhydramine Hydrochloride

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Diphenhydramine Hydrochloride and Chlorpheniramine Maleate are the antihistaminic drugs used in allergic conditions, common cold, etc.  The study was aimed to develop a simple, accurate and precise method for the estimation of Chlorpheniramine Maleate in presence of Diphenhydramine Hydrochloride using it as a divisor and Diphenhydramine Hydrochloride in presence of Chlorpheniramine Maleate using it as a divisor with Methanol as a solvent throughout the experiment. The ICH guidelines have strictly adhered to the validation of this method. Chlorpheniramine Maleate and Diphenhydramine Hydrochloride give linearity in the concentration range from 4.5-9.5 µg/ml. R2 for both DPH and CPM used as a divisor was found to be 0.999 and 0.993 respectively. LOD and LOQ calculated were 1.440µg/ml and 4.365µg/ml and system precision for both DPH and CPM used as a divisor was found to be 1.152% and 1.240% respectively.